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Anesthesia and Cancer Study: Colon Cancer

Primary Purpose

Cancer of Colon, Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cancer of Colon focused on measuring anesthesia, propofol, cancer, inhalational anesthetics

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults undergoing surgery to remove colon cancer

Exclusion Criteria:

  • pregnancy
  • colon cancer with invasion to perineum
  • palliative surgery
  • history of diagnosis or surgery for other cancer
  • emergent surgery
  • ASA PS classification 4 and 5
  • refusion to participate in the study
  • allergy to anesthetics

Sites / Locations

  • Seoul Metropolitan Government Seoul National University Boramae Medical CenterRecruiting
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TIVA

inhalation (Sevoflurane)

Arm Description

propofol infusion targeting bispectral index 40-60

sevoflurane targeting bispectral index 40-60

Outcomes

Primary Outcome Measures

five year survival
survival rate regardless of recurrence

Secondary Outcome Measures

five year recurrence free survival
survival rate without recurrence
1 year recurrence free survival
survival rate without recurrence
3 year recurrence free survival
survival rate without recurrence
1 year survival
survival regardless of recurrence
3 year survival
survival regardless of recurrence

Full Information

First Posted
February 4, 2020
Last Updated
May 3, 2022
Sponsor
Seoul National University Hospital
Collaborators
Korean Society of Anesthesiologists, Bundang Seoul National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Seoul St. Mary's Hospital, Seoul National University Boramae Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04259398
Brief Title
Anesthesia and Cancer Study: Colon Cancer
Official Title
The Influence of Type of Anesthesia on Mortality and Cancer Recurrence After Colon Cancer Surgery: Multi-center Prospective Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 18, 2020 (Actual)
Primary Completion Date
February 1, 2026 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Korean Society of Anesthesiologists, Bundang Seoul National University Hospital, Chung-Ang University Hosptial, Chung-Ang University College of Medicine, Seoul St. Mary's Hospital, Seoul National University Boramae Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No

5. Study Description

Brief Summary
This study investigates the influence of type of anesthesia on survival and recurrence rate in patients receiving colon cancer surgery. The participants will be allocated to either the TIVA group and the inhalation group.
Detailed Description
The effect of anesthesia on cancer recurrence and survival is controversial. According to some retrospective studies and preclinical studies, total intravenous anesthesia (TIVA) is suggested to be more favorable than inhalation anesthesia regarding cancer recurrence and survival after surgery. However, there is no randomized controlled study to determine this difference in colon cancer patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer of Colon, Anesthesia
Keywords
anesthesia, propofol, cancer, inhalational anesthetics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
792 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TIVA
Arm Type
Experimental
Arm Description
propofol infusion targeting bispectral index 40-60
Arm Title
inhalation (Sevoflurane)
Arm Type
Active Comparator
Arm Description
sevoflurane targeting bispectral index 40-60
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
propofol 1-2 mg/kg bolus injection for induction of anesthesia propofol continuous infusion for maintenance of anesthesia
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
sevoflurane is administered for induction and maintenance of anesthesia
Primary Outcome Measure Information:
Title
five year survival
Description
survival rate regardless of recurrence
Time Frame
five years survival
Secondary Outcome Measure Information:
Title
five year recurrence free survival
Description
survival rate without recurrence
Time Frame
five years after surgery
Title
1 year recurrence free survival
Description
survival rate without recurrence
Time Frame
1 year after surgery
Title
3 year recurrence free survival
Description
survival rate without recurrence
Time Frame
3 years after surgery
Title
1 year survival
Description
survival regardless of recurrence
Time Frame
1 year after surgery
Title
3 year survival
Description
survival regardless of recurrence
Time Frame
3 years after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults undergoing surgery to remove colon cancer Exclusion Criteria: pregnancy colon cancer with invasion to perineum palliative surgery history of diagnosis or surgery for other cancer emergent surgery ASA PS classification 4 and 5 refusion to participate in the study allergy to anesthetics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jin-Tae Kim
Phone
+821062608490
Email
jintae73@gmail.com
Facility Information:
Facility Name
Seoul Metropolitan Government Seoul National University Boramae Medical Center
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Kyung Kim, Pf.
Phone
82-2-870-3020
Email
ktkktk@gmail.com
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jin-Tae Kim, Pf.
Phone
+82-2-2072-3295
Email
jintae73@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Anesthesia and Cancer Study: Colon Cancer

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